The invention relates to an orthotic and method for treatment of, substantially preventing, or minimizing the possibility of, human infant occipital plagiocephaly and sudden infant death syndrome (SIDS), serious problems.
In 1992 the American Academy of Pediatrics recommended placing infants on their backs for sleep to reduce the incidence of SIDS, and the technique was considered effective. However, the placement of infants on their backs for sleep also resulted in a significant increase in the incidence of deformational plagiocephaly (flattening of the head). Occipital plagiocephaly is a deformity that can develop when an infant preferentially sleeps in one position on the back of the head (occiput). The deformity that develops is varying degrees of flattening on one or both sides of the occiput. When unilateral, the entire skull base can be deformed into a parallelogram shape. The degree of severity can range from mild to a severe and disfiguring deformity. The incidence is estimated to be anywhere from 3-10 percent of all infants.
Side sleeping was originally considered acceptable as well in the prevention of SIDS. Positioners were created and made widely commercially available for use in side sleep positioning while preventing prone positioning, to thereby reduce the incidence of SIDS. These positioners were also useful in concept to prevent and treat occipital plagiocephaly. However, in 2012, the CDC published a report of thirteen infant deaths over a period of fourteen years associated with wedge or bolster side sleeping devices that were commercially available. This caused the FDA and the American Academy of Pediatrics (AAP) to recommend against the use of these devices. Furthermore, the AAP recommended against side positioning altogether because it was felt that side sleeping was an unstable position and that an infant was more likely to roll to a prone position (than to a supine position), and thus expose them to the risk of SIDS.
There has been really no physiologic reason shown that sleeping in the side position, per se, places an infant at risk for SIDS. It is only a risk because of the potential to allow the infant to roll to a prone position, or move/roll to a position that wedges the baby's face against something soft in the bed causing suffocation. The reason that unilateral plagiocephaly occurs in the first place is that the infant preferentially lies on one side of the occiput. Preventing the infant from preferentially lying on the developed flat side of the occiput is a logical, simple, and proven treatment for this deformity.
Reducing the incidence of preferential pressure applied to the one flat side of the head, (i.e., the force that created the deformity in the first place) allows the rapidly growing infant brain to push the skull out normally and unencumbered, and the deformity self corrects. Having the infant sleep preferentially on the unaffected side is a simple and effective treatment for occipital plagiocephaly, but it must be done safely. Historically, side sleeping positioners were effective in treating occipital plagiocephaly, especially in infants younger than four months who could not roll over well yet on their own. The reason the commercially available wedge or bolster side sleepers were deemed to be unsafe is because their design allowed the infant to still move around while in them. Apparently there were a few deaths identified where it was thought that the infant's face became wedged against the bolster and this caused suffocation.
According to the invention an orthotic and method are provided which allow positioning an infant for side sleeping for prevention or treatment of occipital plagiocephaly.
According to one aspect of the present invention there is provided an orthotic for treating, substantially preventing, or minimizing the possibility of, human infant occipital plagiocephaly and sudden infant death syndrome. The orthotic comprises: A garment having an open top portion, a substantially closed front with right and left sides, and a substantially closed rear with right and left sides, and dimensioned to fit a human infant. At least a first receptacle on the front of the garment. At least a second receptacle on the rear of the garment and operatively associated with the first receptacle. And, first and second bolsters positionable Within the first and second receptacles, respectively, and when positioned therein substantially precluding an infant wearing the garment from rolling over from her or his side to her or his face or back.
The first and second receptacles may be on the left side of the front and rear of the garment, and the garment desirably further comprises third and fourth receptacles on the right side of the front and rear, respectively, of the garment, for receiving one of the first and second bolsters therein. Preferably the bolsters are selected from the group consisting essentially of foam or rubber cylinders and prisms, e. g. having a durometer of between about 40-70 on the Shore A scale.
The garment may be primarily constructed of a stretchable mesh material/fabric. The garment may be selected from the group consisting essentially of a vest and jacket. Desirably the garment has fasteners along the front thereof facilitating placement of the garment on an infant.
The receptacles are desirably selected from the group consisting essentially of sleeves and pockets having fasteners which allow a bolster entry thereinto and removal therefrom. For example, the receptacles may comprise sleeves having open bottoms closed by flaps with fasteners associated therewith for closing the sleeves to retain bolsters therein.
According to another aspect of the present invention there is provided a method of treating, substantially preventing, or minimizing the possibility of human infant occipital plagiocephaly and sudden infant death syndrome, utilizing a garment dimensioned to fit a human infant and having an open top portion, a substantially closed front with right and left sides, a substantially closed rear with right and left sides, a first receptacle on the front, and a second receptacle on the rear operatively associated with the first receptacle. The method comprises: a) providing a bolster in each of the first and second receptacles; b) placing the garment on a human infant; and c) laying the infant on her or his side on a surface so that the bolsters substantially preclude the infant from rolling from her or his side onto her or his face or back on the surface.
In the practice of the method, desirably the first and second receptacles are on the garment left side and third and fourth receptacles are provided on the garment right side and all of the receptacles allow a bolster to be inserted thereinto, and removed therefrom. In such a situation, when c) is practiced to lay the infant on her or his left side a) is practiced to insert bolsters into the first and second receptacles, and to make the third and fourth receptacles bolster-free; and when c) is practiced to lay the infant on her or his right side then a) is practiced to insert bolsters into the third and fourth receptacles and to make the first and second receptacles bolster-free.
The garment used in the practice of the method may be a vest with fasteners closing an opening in the front thereof, and having arm openings, in which case b) is practiced by opening the front of the vest, placing the infant's arms in the arm holes and the infant's head in the open top portion, and closing the front of the vest with the fasteners.
According to yet another aspect of the present invention, a vest or jacket dimensioned to fit a human infant is provided, comprising: A garment having an open top, arm openings, an open front closed by fasteners, a substantially open bottom, and a closed rear. First and second receptacles provided on the front and rear of the left side of the garment. Third and fourth receptacles provided on the front and rear of the right side of the garment. First and second rubber or foam cylindrical or prismatic bolsters dimensioned to fit within the first and second receptacles, or the third and fourth receptacles, respectively. And wherein the receptacles are constructed to allow one of the bolsters to be inserted thereinto and removed therefrom.
The arm openings may be sleeveless so that the garment comprises a vest; and wherein the garment may be primarily constructed of stretchable mesh fabric. The receptacles may comprise sleeves with openings closeable by flaps with fasteners so that when the fasteners associated with a given sleeve and flap are unfastened a bolster can be inserted into that sleeve past that sleeve's flap.
It is the primary object of the present invention to provide an orthotic and method which allow positioning an infant for side sleeping for prevention, minimizing the possibility of, or treatment of occipital plagiocephaly. This and other objects of the invention will become clear from the detailed description of the drawings, and the appended claims.